Registration and Listing of Cosmetic
Product Facilities and Products
On December 11, 2024, The Food and Drug Administration (FDA) issued updated guidance for the cosmetic industry as it pertains to Facility and Product Listing Registration under The Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The guidance clarifies terms, describes who needs to register, lists information needed for submissions, determines when registration occurs, answers commonly asked questions, providing insight on FDA's current thinking on MoCRA Registration.
FDA Q&A Include:
Owner or operators of facilities that manufacture cosmetics are expected to register, while responsible persons are expected to submit product listing.
If a responsible person is located outside the United States, the responsible person's electronic contact information (such as an email or website) should be added to the label.
Examples of products whose manufacture does not qualify for the small business exemption include:
Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual.
Cosmetic products that are injected.
Cosmetic products that are intended for personal use.
Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.
Examples of products that regularly come into contact with the mucus membrane of the eye include eye shadow, eye makeup remover, liquid or mucosal eyeliner, or false eyelash adhesive. Products that generally would not come into contact with the mucus membrane include facial cleansers, facial moisturizers, and facial serums.
Examples of products that are intended to alter appearrance for more than 24 hours include certain nail polishes, some hair dye products, some eyebrow dyes, tattoo inks, and certain leave-on skin preparations.
Laboratories that perform cosmetic batch release testing are required to register.
Storage facilities do not need to register.
Hairbrushes and wigs do not need to register.
Generally, free samples and gifts are required to register.
Under certain circumstances, one FEI number may be associated with multiple buildings that manufacture or process cosmetic products.
FDA intends to periodically update the product categories - all proposed updates will be published on FDA's website.
United Safety Agents
Our firm stands ready to assist.
Phone: +1 (888) 551-7403, or
Hours of Operation
8:00am - 7:00pm (Eastern)
Monday through Friday
Comments